22h ago
Documents Specialist II
Bangalore, Karnataka, India
โจ $35k-$50k / yearest.
full-timesenior Remotehealthcare
๐ Tech Stack
๐ผ About This Role
You'll prepare TMF plans and perform document QC and indexing for clinical trials in a fully remote role. Your work ensures timely document processing and compliance with GCP and regulatory guidelines. You'll collaborate globally on studies for oncology and rare diseases.
๐ฏ What You'll Do
- Perform document QC and indexing within eTMF for assigned studies
- Monitor document submission and timely processing to avoid backlogs
- Distribute TMF metrics to stakeholders
- Manage close-out activities including eTMF export and client transfer
๐ Requirements
- 4-year college degree or equivalent in business, scientific, or healthcare discipline
- Minimum 5 years of clinical trial experience
- Minimum 3 years of experience with TMF and/or eTMF
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint)
โจ Nice to Have
- Working knowledge of ICH-GCP and regulatory guidance
- Experience with oncology or rare disease trials
๐ Benefits & Perks
- ๐๏ธ Remote work flexibility
- ๐ฅ Health insurance
- ๐ Professional development opportunities
- ๐ฐ Competitive compensation
- ๐ Collaborative team environment
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Phone Screenยท 30 min
- 2Technical Interviewยท 45 min
- 3Hiring Manager Interviewยท 45 min
0 0 0